Tamper Evident Closure Container

ABSTRACT

A closure container that can house a preset drug applicator in an easily accessible manner with tamper evidencing means. The closure container contains a plurality of dosing ribs and a retainer to retain the syringe in a preset dosage amount and preferably has a window to view the barrel of the syringe.

RELATED APPLICATIONS

This application is a divisional application of the co-pending U.S.patent application Ser. No. 16/506,753 filed Jul. 9, 2019 and entitled“Tamper Evident Closure Container,” which is a continuation applicationof issued U.S. patent application Ser. No. 15/059,428 filed Mar. 3, 2016and entitled “Tamper Evident Closure Container,” now U.S. Pat. No.10,342,914, which is a continuation application of issued U.S. patentapplication Ser. No. 14/599,202 filed Jan. 16, 2015 and entitled “TamperEvident Closure Container”, now U.S. Pat. No. 9,333,289, all of whichare incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

Success rates with respect to action taken in response to an emergencysituation almost always improve with proper preparation, access to theproper equipment, and speed. This could not be more true than in thecase of providing a dose of fluid (e.g., epinephrine to a patientexperiencing a severe or life-threatening allergic reaction(anaphylaxis)). According to the National Institute of Allergy andInfectious Diseases, early treatment with epinephrine is beneficial topatients having an anaphylactic episode because the patient couldexperience a rapid decline in health or death within 30 to 60 minutes.Such early treatment may also be beneficial in patients experiencingseizure activity.

In addition to quick administration of treatment, accurate dosing iscrucial because not enough medicine may be ineffective and too much maycause health risks, such as dangerously high blood pressure, stroke, ordeath. During an anaphylactic event, for example, a health provider mayneed a larger or smaller dose depending on the size or age of thepatient and fumbling with a vial and a needle may add precious secondsbefore treatment and potential dosing errors.

Further, sterilization is important whenever it comes to administering adrug to a patient through a needle and a health care provider has toknow if the needle being used and the drug being administered have notbeen tampered with. Accordingly, the art of emergency treatment couldbenefit from a device that promotes quick access to a drug applicatorwhich may be stored in pre-set doses and provides evidence of tampering.

SUMMARY OF THE INVENTION

The present invention relates to a closure container, and moreparticularly to a container that can house a preset drug applicator inan easily accessible manner with tamper evidencing means.

An embodiment of a method according to the present invention includesmanufacturing a first casing member, a second casing member coupled tothe first casing member at a hinge location, and a fastener capable ofsecuring the first casing member to the second casing member oppositethe hinge location, the fastener having a tamper evident pull tab,wherein one of the first or second casing member includes a window. Themethod also includes the steps of covering an area on one of the firstor second casing member in which the window is to be located, treatingthe first or second casing member to decrease the transparency of thefirst or second casing member, and removing the covering to reveal thewindow.

According to another embodiment of a method according to the presentinvention, the window is transparent to visible light.

According to still another embodiment of a method according to thepresent invention, the treating step also includes the step ofchemically etching the first or second casing member.

According to yet another embodiment of a method according to the presentinvention, the treating step also includes the step of mechanicallyetching the first or second casing member.

According to a further embodiment of a method according to the presentinvention, the treating step also includes the step of adding textureddies to the manufacturing process of the first or second casing member.

According to a further embodiment of a method according to the presentinvention, the method further includes the steps of providing a syringecontaining a predetermined amount of fluid, positioning the syringebetween the first casing member and the second casing member, andsecuring the first casing member to the second casing member, wherein atleast a portion of the syringe and the predetermined amount of fluidamount are visible through the window.

An embodiment of a method according to the present invention includesmanufacturing a first casing member, a second casing member, a syringecontaining a predetermined amount of fluid, and a fastener having atamper evident pull tab. In this embodiment, the first casing memberincludes at least one catch and the second casing member includes atleast one hole configured to be mateable with a catch. The methodfurther includes the steps of combining the above components to form asystem and stacking a plurality of systems.

According to another embodiment of a method according to the presentinvention, the method further includes steps of configuring the at leastone catch to have an L-shape profile, where a body of the catch extendsperpendicularly from the first casing member and an arm of the catchextends from the body.

According to yet another embodiment of a method according to the presentinvention, the stacking process includes mating at least one catch ofone system with at least one hole of another system.

According to still another embodiment of a method according to thepresent invention, the mating process means inserting the arm and bodyof a catch of one system into a hole of another system and sliding thesystems in opposite directions relative to one another.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of a tamper evidentclosure container according to the present invention.

FIG. 2 is a perspective view of the container shown in FIG. 1 in an openstate and holding a syringe.

FIG. 3 is another perspective view of the container shown in FIG. 1 inan open, empty state.

FIG. 4 is a top plan view of the container shown in FIG. 1.

FIG. 5 is a bottom plan view of the container shown in FIG. 1.

FIG. 6 is a front elevation view of the container shown in FIG. 1.

FIG. 7 is a rear elevation view of the container shown in FIG. 1.

FIG. 8 is a right side elevation view of the container shown in FIG. 1.

FIG. 9 is a left side elevation view of the container shown in FIG. 1.

FIG. 10 is a top plan view of the container as shown in FIG. 3.

FIG. 11 is a bottom plan view of the container as depicted in FIG. 3.

FIG. 12 is a front elevation view of the container as shown in FIG. 3.

FIG. 13 is a rear elevation view of the container as depicted in FIG. 3.

FIG. 14 is a right side elevation view of the container as shown in FIG.3.

FIG. 15 is a left side elevation view of the container as depicted inFIG. 3.

FIGS. 16-19 depict a progressive method of enclosing a syringe in thefirst embodiment of the container according to the present invention.

FIG. 20 is a cross-sectional view along line 20-20 of FIG. 19.

FIG. 21 is a perspective view of a plurality of containers according tothe first embodiment of the present invention stacked one on top of theother.

FIG. 22 is a selected cut-away view of FIG. 21.

FIG. 23 is a perspective view of a second embodiment of a tamper evidentclosure container according to the present invention.

FIG. 24 is a perspective view of a plurality of containers according tothe second embodiment of the present invention stacked one on top of theother.

FIG. 25 is a cut-away view of selected section FIG. 25 of FIG. 24.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention which may be embodied inother specific structures. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention, which is defined by the claims.

Turning first to FIG. 1, a first embodiment 10 of a closure containeraccording to the present invention is shown. The closure container 10preferably comprises a single injection-molded piece having a firstcasing member 100 hingedly attached to a second casing member 200 by atleast one hinge 12 (see FIG. 2), which may be a living hinge.

The first casing member 100 may generally be formed along a longitudinallength between and including a first end 102 opposite a second end 104,an outer surface 106, a peripheral edge portion 116 (FIG. 2), a fastener118, and an inner surface 132 (FIG. 2).

The outer surface 106 of the first casing member 100 extends from thefirst end 102 to the second end 104 and to the peripheral edge portion116. The outer surface 106 has a planar portion 108 with a window 110preferably provided therein and a plurality of catches 112 projectingtherefrom.

Each catch 112 preferably has an L-shape profile and extends outwardfrom the planar portion 108, whereby an arm 114 of the L-shape is spacedfrom and substantially parallel with the planar portion 108 of the outersurface 106, and all of the catches 112 are oriented preferably in thesame direction.

The fastener 118 is flexibly connected at or near the peripheral edgeportion 116 of the first casing member 100 opposite the hinge 12. Thefastener 118 has a width 120, a thickness 122, an exterior surface 124,an interior surface 126, and a tamper-evident pull-tab 130. A barb 128projects from the interior surface 126 distal to the outer surface 106of the first casing member 100.

The tamper-evident pull-tab 130 preferably extends substantiallyperpendicular from the fastener 118 between the barb 128 and the outersurface 106 of the first casing member 100. The tamper-evident pull-tab130 is preferably offset from the exterior surface 124 of the fastener118 in a direction away from the container 10 when the fastener 118 isin an engaged position, as discussed further below.

The inner surface 132 of the first casing member 100 can be seen inFIGS. 2 and 3. The inner surface 132 extends from the first end 102 tothe second end 104 and to the peripheral edge portion 116, andpreferably has an at least substantially planar portion 134. As shownhere, a bridge 136 with a notch 138 projects from the planar portion 134of the inner surface 132 near the first end 102 to or near theperipheral edge portion 116.

A retainer 140 extends from the planar surface 134 to or near theperipheral edge portion 116 and comprises a first wall 142, with a firstwall notch 144, and a second wall 146, with a second wall notch 148,substantially parallel to the first wall 142.

A plurality of dosing ribs 152 project from the planar portion 134 to ornear the peripheral edge portion 116 and are spaced between the secondend 104 and the second wall 146 of the retainer 140. Each dosing rib 152has a notch 154, an innermost side 156 (hidden), and an outermost side158. The spacing between the dosing ribs 152 relates to thepredetermined dosage provided in a syringe 50 (FIG. 2) to be containedwithin the closure container 10. The preferable dosing amounts for whichthe ribs 152 will be spaced are 0.25 mL, 0.5 mL, 0.75 mL, and 1.0 mL,but other dosing amounts are contemplated.

The second casing member 200 may be seen in FIGS. 2 and 3 as well. Thesecond casing member 200 has a first end 202 opposite a second end 204,an outer surface 206, a peripheral edge portion 216, and an innersurface 232.

The outer surface 206 of the second casing member 200 extends from thefirst end 202 to the second end 204 and to the peripheral edge portion216. The outer surface 206 preferably has an at least substantiallyplanar portion 208 with a plurality of holes 260 (FIG. 5) therein whichare sized, positioned, and configured to be mateable with the catches112 of the first casing member 100 of another closure container 10.

As shown in FIGS. 10 and 11, the outer surface 206 of the second casingmember 200 has a recess 262 with a width 264 slightly greater than thewidth 120 of the fastener 118 and a depth 266 preferably similar to thethickness 122 of the fastener 118. A slot 268 sized and configured toreceive the barb 128 of the fastener 118 is provided within the recess268.

Looking back to FIGS. 2 and 3, the inside surface 232 of the secondcasing member 200 is shown. The inside surface 232 of the second casingmember 200 is preferably substantially similar to the inside surface 132of the first casing member 100. As shown here, the inner surface 232extends from the first end 202 to the second end 204 and to theperipheral edge portion 216, and preferably has a planar portion 234. Asshown here, a bridge 236 with a notch 238 projects from the planarportion 234 of the inner surface 232 near the first end 202 to or nearthe peripheral edge portion 216.

A retainer 240 extends from the planar portion 208 to or near theperipheral edge portion 216 and comprises a first wall 242, with a firstwall notch 244, and a second wall 246, with a second wall notch 248,substantially parallel to the first wall 242. The first wall 242 isspaced apart from the second wall 246 a distance 250.

A plurality of dosing ribs 252 project from the planar portion 234 ofthe inner surface 232 to or near the peripheral edge portion 216 and arespaced between the second end 204 and the second wall 246 of theretainer 240. Each dosing rib 252 has a notch 254, an innermost side256, and an outermost side 258. The spacing between the dosing ribs 252relates to the predetermined dosage provided in a syringe 50 (FIG. 2) tobe contained within the closure container 10. The preferable dosingamounts for which the ribs 252 will be spaced are 0.25 mL, 0.5 mL, 0.75mL, and 1.0 mL, however, other dosing amounts are contemplated.

Additionally or alternatively, the dosing ribs 152 of the first casingmember 100 may be staggered from the dosing ribs 252 of the secondcasing member 200 to provide more dosing options while still providingsecure support of the syringe 50 and the plunger 52.

Additionally or alternatively, the first casing member 100 or the secondcasing member 200 may not contain the respective dosing ribs, retainer,or the bridge; instead being configured simply to cover the other casingmember 200,100.

Looking back to FIG. 1 and also to FIGS. 4-9, the closure container 10is depicted in from various views with the syringe 50 positioned withinthe container 10 and the fastener 118 engaged with the second casingmember 200. As shown, when the container 10 is in a closed position, thefastener 118 preferably resides substantially within the recess 262,with the barb 128 received within the slot 268.

The material from which the closure container 10 is formed is preferablyinitially transparent. The window 110 is preferably formed by coveringthe area in which the window 110 will be located, treating at least theouter surfaces 106,206 of the first casing member 100 and the secondcasing member 200, respectively, to decrease the transparency of thosesurfaces, and removing the covering to reveal the window 110. Thetreatment may be performed by any process now known or later discovered,including but not limited to, chemical etching, mechanical etching(e.g., sand blasting), or during the molding process using textureddies. Continuing to look at FIG. 1, a syringe 50 can be viewed throughthe window 110 in a pre-set dosage configuration, ready for use. Thewindow 110 is preferably located at least radially outward from thebarrel 64 of the syringe 50 to provide a care provider with a view ofthe syringe 50 and preferably the dosage amount provided in the barrel64 without having to open the closure container 10.

Directing attention to FIGS. 16-19, the installation of the syringe 50into the container 10 is shown. FIG. 16 illustrates the syringe 50 witha predetermined dosage provided in the barrel 64 prior to placementwithin the second casing member 200; however, the syringe 50 may beplaced within the first casing member 100 as well, as shown in FIG. 17.

Looking to FIG. 17, with reference to FIG. 16, the flange 60 of thesyringe 50 is placed within the retainer 140 of the first casing member100 with a portion of the barrel 64 received by the notch 144 of thefirst wall 142 and another portion of the barrel 64 received by thenotch 138 of the bridge 136. Preferably, the distance 150 between thefirst and second walls 142,146 of the retainer 140 (FIG. 10) ispreferably slightly greater than the thickness 62 of the syringe flange60.

The top 54 of the plunger 52 has a topside surface 56 and an undersidesurface 58. When installed within the container 10, the undersidesurface 58 of the syringe top 54 preferably resides against or near theoutermost side 158 of the respective dosing rib 152. The placement ofthe flange 60 within the retainer 140 and the top 54 against the dosingrib 152 reduces the likelihood that the syringe 50 will be accidentallydischarged prior to use.

FIG. 18 illustrates the closing of the container 10 with the first andsecond casing members 100,200 rotating about the hinge 12 (FIG. 17) andadjoining the first casing member peripheral edge portion 116 (FIG. 17)with the second casing member peripheral edge portion 216 (FIG. 17). Thebarrel 64 of the syringe 50 is thereby also received within the bridgenotch 238, the retainer 240, and the respective dosing rib notch 254 ofthe second casing member 200 (see FIG. 17).

Looking to FIGS. 19 and 20, the engagement of the fastener 118 is shown.The fastener 118 is wrapped around the outside surface 206 of the secondcasing member 200 within the recess 262. The barb 128 is engageablyreceived within the slot 268 to retain the fastener 118 in the engagedposition.

When the time comes for the syringe 50 to be removed from the container10, the health care personnel will pull the tamper-evident pull-tab 130away from the container 10 which will tear through the fastener 118 andsever the fastener's connection between the first and second casingmembers 100,200, thus allowing the container 10 to be opened and thesyringe 50 to be removed.

Removal of the tamper-evident pull-tab 130 permanently detaches at leasta portion of the fastener 118 from the first casing member 100 whenpulled to gain access to the syringe 50. Therefore, tampering with thefastener 118 or the tamper-evident pull-tab in an attempt to gain accessto the syringe 50 will be visibly noticeable by a tear in the fastener118.

FIGS. 21 and 22 demonstrate how multiple containers 10A,10B,10C may bestacked one on top of the other.

As shown in greater detail in FIG. 22, a mateable stacking interactionbetween a catch 112A and a hole 260B is shown. The interaction allowsthe containers 10A,10B to be removably interlocked. The catch 112A,along with the other three catches (not shown), of the first container10A are inserted within the holes 260B of the second container 10B andthe containers 10A,10B, are slid in opposite directions relative to oneanother to place the arm 114A of the first container 10A adjacent to theinner surface 232B of the second container second casing member 200B.These actions are depicted by the dashed lines in FIG. 21.

FIG. 23 illustrates a second embodiment 20 of the closure containeraccording to the present invention. The closure container 20 has tabs470 projecting from the planar portion 408 of the second casing memberouter surface 406 and apertures 390 (FIG. 24) provided through theplanar portion 308 of the first casing member outer surface 306. Theapertures 390 are alignable and mateable with the tabs 470 of acorresponding closure container 20.

Each tab 470 has a width 472 (FIG. 24), an inward face 476, and anoutward face 480. The tabs 470 preferably extend substantiallyperpendicular away from the outside surface planar portion 408 andcomprise a protuberance 478, or similarly shaped protrusion, on theinward face 476 at or near the distal end portion 482 (FIG. 25) of eachtab 470. Alternatively, it is contemplated that the protuberance 478 mayprotrude from the outward face 480.

The apertures 390 have a width 392 and an abutting surface 396. Thewidth 392 of the apertures 390 is preferably slightly greater than thewidth 472 of the tabs 470.

FIGS. 24 and 25 demonstrate how multiple containers 20A,20B,20C may bestacked by inserting the tabs 470B of a second container 20B within theapertures 390A of a first container 20B. This action is depicted by thedashed lines in FIG. 24. In this fashion, stacking of these embodiments20 require only a singular directional movement, rather than thecompound movement that may be utilized to stack cases according to thefirst embodiment 10.

FIG. 25 more closely illustrates the interaction between a tab 470B ofthe second container 20B is received within an aperture 390 of the firstcontainer 20A to provide a releasable connection between the twocontainers 20A,20B. Preferably, the inner face 476B of the tab 470B issubstantially flush with the abutting surface 396A of the aperture 390A,whereby the protuberance 478B of the tab 470B is in contact with theplanar portion 334A of the first casing member inner surface 332A andthe first container's second casing member outer surface planar portion308A is flush with the second container's first casing member outersurface planar portion 408B.

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

We claim:
 1. A method comprising the steps of: manufacturing a firstcasing member, a second casing member coupled to the first casing memberat a hinge location, and a fastener capable of securing the first casingmember to the second casing member opposite the hinge location, thefastener having a tamper evident pull tab, wherein one of the first orsecond casing member includes a window; covering an area on one of thefirst or second casing member in which the window is to be located;treating the first or second casing member to decrease the transparencyof the first or second casing member; and removing the covering toreveal the window.
 2. The method of claim 1, wherein the window istransparent to visible light.
 3. The method of claim 1, the treatingstep further comprising the step of: chemically etching the first orsecond casing member.
 4. The method of claim 1, the treating stepfurther comprising the step of: mechanically etching the first or secondcasing member.
 5. The method of claim 1, the treating step furthercomprising the step of: adding textured dies to the manufacturingprocess of the first or second casing member.
 6. The method of claim 1,further comprising the step of: providing a syringe containing apredetermined amount of fluid; positioning the syringe between the firstcasing member and the second casing member; and securing the firstcasing member to the second casing member, wherein at least a portion ofthe syringe and the predetermined amount of fluid amount are visiblethrough the window.
 7. A method comprising the steps of: manufacturing afirst casing member, a second casing member, a syringe containing apredetermined amount of fluid, and a fastener having a tamper evidentpull tab, wherein the first casing member includes at least one catchand the second casing member includes at least one hole configured to bemateable with a catch; combining the above components to form a system;and stacking a plurality of systems.
 8. The method of claim 7, themanufacturing step further comprising: configuring the at least onecatch to have an L-shape profile, wherein a body of the catch extendsperpendicularly from the first casing member and an arm of the catchextends from the body.
 9. The method of claim 10, the stacking stepfurther comprising: mating at least one catch of one system with atleast one hole of another system.
 10. The method of claim 9, the matingstep further comprising: inserting the arm and body of a catch of onesystem into a hole of another system; and sliding the systems inopposite directions relative to one another.